A Study to Assess the Efficacy and Safety of Lorundrostat in Participants With Obstructive Sleep Apnea and Hypertension

Last updated: May 12, 2025
Sponsor: Mineralys Therapeutics Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Circulation Disorders

Sleep Apnea Syndromes

Stress

Treatment

Placebo

Lorundrostat

Clinical Study ID

NCT06785454
MLS-101-207
  • Ages 18-75
  • All Genders

Study Summary

The primary purpose of the study is to assess the effect of lorundrostat taken orally (po) once a day on the Apnea-Hypopnea Index (AHI) in participants with moderate to severe obstructive sleep apnea (OSA) and hypertension.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Body mass index (BMI) ≥ 27 kilograms per meter square (kg/m^2)

  2. Previously diagnosed with moderate-to-severe OSA

  3. AHI ≥15 events per hour (/hr) prior to Randomization

  4. AOBP SBP of ≥130 and less than or equal to (≤) 160 millimeter of mercury (mmHg) andAOBP diastolic blood pressure (DBP) ≥60 and ≤110 mmHg

  5. Participants on CPAP or PAP therapy are eligible provided they are on PAP for ≥4hours per night and for at least 3 months prior to the study enrollment

  6. Participants not currently on PAP therapy, and not anticipated to start PAP for theduration of the study

  7. Fertile male and female participants of childbearing potential, and their partners,must agree to use protocol-defined methods of highly effective contraception fromthe Screening Visit until 28 days after the last dose of study drug

Exclusion

Exclusion Criteria:

  1. Type 2 diabetes mellitus (T2DM) with a glycosylated hemoglobin (HbA1c) greater than (>) 9 percent (%) (>74.9 millimoles per mol [mmol/mol]) at the Screening Visit orhistory of diabetic ketoacidosis in the 6 months prior to the Screening Visit

  2. Participants on a glucagon-like peptide-1 (GLP-1) agonist.

  3. Any planned surgery for sleep apnea or major ear, nose or throat surgery, includingtonsillectomy and adenoidectomy during trial participation.

  4. Have diagnosis of central or mixed sleep apnea with % of mixed or centralapneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration

  5. Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia

  6. Use of bilevel positive airway pressure (BiPAP) therapy.

  7. History of clinically significant hyponatremia within 1 year prior to Screening

  8. eGFR less than (<) 45 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2)at Screening

  9. History of clinically relevant medical, behavioral, or psychiatric disorder, otherthan OSA, that is associated with insomnia or excessive sleepiness

  10. Diagnosed with Child-Pugh Class C

  11. Participants who regularly use caffeine stimulants or participants who are unwillingto reduce intake to 300 mg per day (approximately 3 cups of coffee), 1 week prior toScreening

  12. Treatment with MRAs and/or epithelial sodium channel (ENaC) inhibitors within 1month of the Screening Visit

  13. Use of supplemental oxygen

  14. Women who are pregnant, plan to become pregnant, or are breastfeeding

  15. Hospitalization for the treatment of urgent or emergent hypertension within 1 yearprior to Screening

  16. Unstable or currently symptomatic cardiovascular disease or hospitalization in the 6months prior to Screening

  17. Previously diagnosed, recurrent orthostatic hypotension

  18. Current night-shift worker or anticipated to become a night-shift worker for 3 dayscontinuously during the duration of the study

  19. Classified as a New York Heart Association (NYHA) Class III or IV at the ScreeningVisit

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 28, 2025
Estimated Completion Date:
January 31, 2026

Study Description

The study is a randomized, double-blind (DB), placebo controlled, crossover study. A 3-week screening period is followed by two DB 4-week treatment periods separated by a 2-week washout period. Participants must be 18 to 75 years of age with moderate to severe OSA, hypertension and meet all applicable eligibility criteria. Participants who are medically prescribed and deemed compliant with positive airway pressure (PAP) therapy for greater than or equal to (>=) 4 hours per night (Continuous PAP [CPAP], or automatic PAP [autoPAP]) and for at least 3 months prior to the study enrollment are eligible for the study. Participants on PAP therapy should comply with PAP therapy for the duration of the study. Participants who are not currently on PAP therapy and not anticipated to start PAP for the duration of the study, are also eligible for the study.

Connect with a study center

  • The University of Alabama

    Tuscaloosa, Alabama 35401
    United States

    Site Not Available

  • Chandler Clinical Trials

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Preferred Research Partners Inc.

    Little Rock, Arkansas 72211
    United States

    Active - Recruiting

  • Orange County Research Institute

    Anaheim, California 92801
    United States

    Active - Recruiting

  • The Neurology Center of Southern California - Profound Research, LLC

    Carlsbad, California 92011
    United States

    Site Not Available

  • Probe Clinical Research Corporation

    Riverside, California 92501
    United States

    Active - Recruiting

  • Headlands Research - Peninsula Research Associates

    Rolling Hills Estates, California 90274
    United States

    Site Not Available

  • Research Carolina Elite

    Denver, Colorado 28037
    United States

    Active - Recruiting

  • Nouvelle Clinical Research

    Cutler Bay, Florida 33189
    United States

    Site Not Available

  • Arrow Clinical Trials

    Daytona Beach, Florida 32117
    United States

    Active - Recruiting

  • PharmaDev Clinical Research Institute, LLC

    Miami, Florida 33176
    United States

    Active - Recruiting

  • CNS Healthcare - Orlando (Clinical Neuroscience Solutions)

    Orlando, Florida 32801
    United States

    Active - Recruiting

  • NeuroTrials Research Inc

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Centricity Research Rincon Pulmonology

    Rincon, Georgia 31326
    United States

    Site Not Available

  • Chicago Research Center Inc

    Chicago, Illinois 60634
    United States

    Active - Recruiting

  • Centennial Medical Group

    Columbia, Maryland 21045
    United States

    Site Not Available

  • Velocity Clinical Research, Rockville

    Rockville, Maryland 20854
    United States

    Site Not Available

  • Henry Ford Health System/Henry Ford Medical Center - Columbus

    Novi, Michigan 48377
    United States

    Site Not Available

  • Revive Research Institute, Inc

    Southfield, Michigan 48075
    United States

    Active - Recruiting

  • Healthcare Research Network

    Hazelwood, Missouri 63042
    United States

    Site Not Available

  • Clayton Sleep Institute

    Saint Louis, Missouri 63123
    United States

    Active - Recruiting

  • Patient First MD

    Middletown, New Jersey 07748
    United States

    Site Not Available

  • The Sleep Spot Maimonides

    Albuquerque, New Mexico 87107
    United States

    Active - Recruiting

  • CTI Clinical Research Center

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • Northwest Research Center

    Portland, Oregon 97202
    United States

    Active - Recruiting

  • CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis)

    Memphis, Tennessee 38119
    United States

    Active - Recruiting

  • Huntsville Research Institute LLC

    Huntsville, Texas 77340
    United States

    Active - Recruiting

  • Sleep Therapy Research Center

    San Antonio, Texas 78229
    United States

    Site Not Available

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